Dry Heat Sanitizer and Method of Use

ABSTRACT

A sanitizer system and method of use is disclosed. The sanitizer system quickly sanitizes and cools targeted objects and secures the targeted sanitized objects for later use, without the need to transfer the objects to a separate container. In one embodiment, the sanitizer system comprises a cassette having a body and a removable lid that, when joined, form an airtight chamber for containing an object for sterilization. A pressure control element of the system is configured to fluidly engage with the cassette to produce a pressure-controlled environment within the airtight chamber. A heating element of the system, which is interconnected and in thermal communication with the airtight chamber, is configured to provide heat to the airtight chamber. The chamber temperature is raised to a desired temperature for a period of time sufficient to sanitize the object. A cooling element of the system is configured to cool the chamber and the object.

CROSS-REFERENCE

This application is a continuation of U.S. patent application Ser. No.15/055,320, filed Feb. 26, 2016 (now U.S. Pat. No. 10,105,458, issuedOct. 23, 2018), which claims the benefit of U.S. Provisional ApplicationNo. 62/121,011 (Attorney Docket No. 49966-703.101), filed Feb. 26, 2015,which application is incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

Embodiments are generally related to a sanitizing system, and, inparticular, to a dry heat sanitizer and method of use.

Existing sanitizing systems use a variety of sanitizing means to clean,reduce microbial contamination, or sterilize equipment. Each of thesanitizing means carry relative limitations such as time required toclean or sterilize the targeted equipment, total cycle time to includeany heating or cooling-off time, stress or wear to the targetedequipment, material composition requirements, sanitizing temperature,energy or power demands, and management of the targeted equipment oncecleaned or sterilized. The existing systems provide a compromise of theabove limitations. Conventionally, sanitized equipment is transferred toa separate container or sealed bag prior to use, e.g. in a dental careapplication.

Existing dry heat methods of sanitization have relatively slowercool-to-cool cycle time, i.e. the total cycle time from start to finishof the sanitization process or from insertion to removal of the coolinstruments, including any heating or cooling-off time. Furthermore,with new standards for infection control, dry heat poses an elongatedsanitization time, especially when needing to bag the sanitizedinstruments. A longer sanitization time requires an office to keep moreinstruments on hand to keep up with the number of patients beingattended. Present standards require bagging within a reasonable timeafter sanitization, meaning the instruments come into contact with theambient environment after sanitization, which can contaminate thesanitized instruments.

Autoclaves utilizing steam have relatively decreased cycle time (due tothe lower temperature requirements) and can be bagged pre-sanitization.However, the steam is known to dull instruments, leading to higher costin instrument purchase from decreased instrument lifetime. Another issuewith bagging is there is no way to determine if the sanitized bag hasbeen contaminated post sanitization, by the ambient environment or otherfactors, due to a hole or perforation in the bag (typically not visibleto the naked eye). Finally, the use of bags in general and necessity forwater in steam autoclaves are not eco-friendly because the plastic isdisposed of after each use and the water must be continuallyreplenished.

Existing dry heat sanitizers work by convection: air in a chamber isheated and flows around stainless steel instruments. Some issued USpatents describe different patterns of air flow and designs of cassettes(containers) that hold the instruments. Some designs load instruments ina rack or shelf in the sanitizer. Typical dry heat sanitizationtime/temperature is 6 minutes at 375° F. Usually the instruments areleft in the chamber to cool; one important variable is total cycle timefrom insertion to removal of the cool instruments—typically a 40 minutecycle.

Current practice in a dental or medical office is to remove sanitizedinstruments when cool and place them in bags until needed for a patient.Disadvantages of this approach include cost of the bags. Furthermore,several states have laws and/or regulations that require instruments tobe bagged after removal from a dry heat sanitizer or sterilizer.

A conventional approach to sanitization of medical equipment is throughconvection, such as by blowing hot air over objects targeted forsanitization. U.S. Pat. Nos. 4,923,681 and 6,039,926, and U.S. PatentApplication Publication No. 2013/0078161, each of which is incorporatedherein by reference in its entirety, provide examples of thisconventional approach. Generally, the convection-style sterilizingdevices, as disclosed in the examples listed above, have practicaloperational deficiencies. For example, once sanitized objects orinstruments are removed from the sanitization device, they are exposedto ambient office conditions and will no longer be sterile. In someapplications (e.g. typical hospital applications), if sanitizedinstruments are not used immediately, the instruments must be maintainedas sanitized until used. Thus, it would be advantageous to provide asingle container that overcomes some of these challenges. In dentalapplications, instruments can be bagged prior to sanitization and willremain sanitized in the bag until opened. However, the cost and wasteassociated with the use of bags that may be sanitized or sterilized ispreferred to be avoided, thus again motivating a single container thatavoids or overcomes some of these issues.

Other conventional approaches to sanitization using heat include U.S.Pat. Nos. 4,376,096 and 5,396,049, WO 93/12841, and WO 2014/104940, eachof which is incorporated herein by reference in its entirety.Additionally, efforts to improve the design of sanitization containersinclude, for example, U.S. Pat. Nos. 4,617,178, 5,353,930, WO2014/159696 A1, U.S. Patent Application Publication No. 2003/0211023,and EP 2510953, each of which is incorporated herein by reference in itsentirety.

It would therefore be advantageous to provide a sanitizing system andmethod of use that quickly sanitizes and cools targeted objects andsecures the targeted sanitized objects for later use, without the needfor transfer the sanitized objects to a separate container. Thisdisclosure meets at least some of these objectives.

SUMMARY OF THE INVENTION

In one aspect, a sanitizer system comprises: a cassette comprising abody and a removable lid, the body and the removable lid forming anairtight chamber through an airtight seal when joined together, theairtight chamber configured to contain an object for sanitization; apressure control element configured to fluidly engage with the cassetteand produce a pressure-controlled environment within the airtightchamber; a heating element in thermal communication with the airtightchamber, the heating element configured to provide heat to the airtightchamber; wherein the heat provided by the heating element raises atemperature within the airtight chamber to a desired temperature and fora period of time sufficient to sanitize the object for sanitization; anda cooling element in thermal communication with the airtight chamber,the cooling element configured to lower the temperature within theairtight chamber such that the object for sanitization is cooled.

The thermal communication between the heating element and the airtightchamber and the thermal communication between the cooling element andthe airtight chamber of the sanitizer system may be via thermalconduction or thermal convection. In addition, the heating element maybe in surface contact with the cassette and may also further comprise aplurality of elongated heating members separated by alternating gapsforming a heating platform having a substantially planar heatingsurface, wherein the heating platform conducts heat in a substantiallyeven manner over a surface of the cassette. Alternatively, the heatingelement may be disposed inside the cassette to heat the airtight chamberand may further comprise electrical contacts exiting the lid of thecassette through sealed openings.

The cooling element of the sanitizer system may comprise an activecooling element, including for example, a thermoelectric cooler. Thecooling element may be configured to be in surface contact with thecassette such that the cooling element reduces the temperature of thecassette. In addition, the cooling element may further comprise aplurality of elongated cooling members separated by alternating gapsforming a cooling platform having a substantially planar coolingsurface.

The sanitizer system may further comprise an actuator element, whereinthe actuator element is configured to move one of the heating or coolingelement relative to the other of the heating or cooling element.Moreover, the cassette may only be in surface contact with one of theheating or cooling element when it is in a raised or a lowered positionwith respect to the other of the heating or the cooling element. One ofthe heating or cooling element may comprise an opening therein and theother of the heating or cooling element may be moved through the openinginto a raised or lowered position relative to the heating or coolingelement with the opening.

The pressure control element may comprise a vacuum element configured toengage with the cassette and evacuate air from the airtight chamber toproduce a vacuum environment therein, wherein the vacuum element maycomprise a valve to control or monitor the vacuum environment, whereinthe valve may be configured to provide an audible or visual indicationthat the airtight seal has been broken by actuating the valve from aclosed position to an open position.

The sanitizer system may further comprise an indicator, such as, forexample, a pressure gauge, having indicia that indicate a degree ofpressure or vacuum established in the airtight chamber. The pressurecontrol element of the sanitizer system may comprise an insertionelement that may be configured to fluidly engage with the cassette andinsert a fluid into the airtight chamber to produce a pressurizedenvironment within the airtight chamber. The insertion element maycomprise a valve to control or monitor the pressurized environment.

The sanitizer system may further comprise a filter, which may sanitizethe fluid. The cassette may comprise an input and an output valve,wherein the input and the output valve may each have an open and aclosed position, and wherein when both the input and the output valveare in the open position, filtered fluid may be delivered through theinput valve filling the cassette with filtered fluid and forcingunfiltered fluid out of the output valve. The fluid may comprise aliquid or a gas, including but not limited to air, an inert gas, such asargon or neon, or a non-oxidizing gas, such as nitrogen.

The cassette may be removably disposed on the heating element or thecooling element of the sanitizer system. In addition, the cassette maycomprise an alignment element on a top surface of the cassette and amating element on a bottom surface of the cassette configured to alignand mate with an adjacent cassette having an alignment element and amating element.

The heat provided by the heating element may raise the temperaturewithin the airtight chamber of the sanitizer system to a temperature andfor a period of time sufficient to sterilize the object for sanitizationto a level suitable for dental use or surgical use.

In another aspect, a method of sanitizing an object comprises: providingan object for sanitization; placing the object for sanitization within acassette comprising a body and a removable lid; joining the body andremovable lid of the cassette to form an airtight chamber containing theobject for sanitization; controlling a pressure in the airtight chamber;heating the airtight chamber using a heating element to raise thetemperature within the airtight chamber and thereby sanitizing theobject for sanitization contained within the airtight chamber;maintaining the temperature for a designated period of time sufficientto sanitize the object for sanitization; and cooling the object forsanitization.

The method may further comprise moving one of the heating element or acooling element relative to the other of the heating element or coolingelement such that the cassette is only in surface contact with eitherthe heating element or the cooling element. One of the heating elementor the cooling element may comprise an opening, and the method mayfurther comprise moving or passing one of the heating element or thecooling element through the opening in the other of the heating elementor the cooling element. Heating the airtight chamber may compriseheating the airtight chamber through thermal conduction, through thermalconvection, by contacting a surface of the cassette with the heatingelement, or by heating with the heater element disposed inside thecassette. Cooling the object for sanitization may comprise contacting asurface of the cassette with a cooling element and may further compriseactive cooling, including for example, thermoelectrically cooling.Placing the object for sanitization within the cassette may compriseplacing the object such that it is in surface contact with the cassette.

Producing a pressure-controlled environment within the airtight chambercontaining the object for sanitization may comprise evacuating fluidfrom or disposing fluid into the airtight chamber to either decrease orincrease the pressure in order to produce a vacuum or pressurizedenvironment within the airtight chamber. The method may further comprisecontrolling or monitoring the vacuum or pressurized environment withinthe airtight chamber after the object for sanitization has beensanitized by using an audible, visual, or other indicator known in theart that the cassette is still under vacuum or is still pressurized. Thecassette may comprise an input valve and an output valve, and the methodmay further comprise: opening the input valve, opening the output valve,passing a filtered fluid through the input valve into the chamber,forcing unfiltered fluid from the chamber through the output valve,pressurizing the chamber, and closing both valves. The method mayfurther comprise removing the cassette from the heating element or thecooling element and may also comprise stacking the cassette on top of anadjacent cassette. Sanitizing the object for sanitation may furthercomprise sterilizing the object for sanitization to a level suitable fordental use or surgical use.

The terms “sanitize” and “sanitary” or variations thereof refer toactions needed, such as disinfecting or cleaning, to remove or reducepathogenic microorganisms and their habitats from an object or anenvironment.

The term “sterilize” or variations thereof refers to sanitizing to alevel suitable for dental use or surgical use, typically by bringing toa high temperature.

The term “autoclave” or variations thereof refers to an apparatus forsanitizing or sterilizing objects, such as surgical instruments, bymeans of steam under pressure.

The term “convection” or variations thereof refers to heat transferthrough a gas or liquid by the circulation of currents from one regionto another.

The term “conduction” or variations thereof refers to heat transferthrough a conducting medium without perceptible motion of the mediumitself, such as by a metallic connector medium.

The term “radiation” or variations thereof refers to the emission ortransfer of radiant energy as particles, electromagnetic waves, sound,etc.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the invention andtogether with the general description of the invention given above, andthe detailed description of the drawings given below, serve to explainthe principals of this invention.

FIGS. 1A-1B show an exemplary embodiment of a sanitizer system;

FIG. 1C shows a photograph of the exemplary embodiment of FIGS. 1A-1B;

FIGS. 2A-2B show a perspective view of a cassette that may be used in anexemplary embodiment of a sanitizer system;

FIGS. 3A-3B show a top and cross-sectional side view respectively of aremovable lid for a cassette;

FIGS. 4A-4B show a top and cross-sectional side view respectively of acassette body;

FIG. 5 shows a cross-sectional view of a cassette;

FIGS. 6A-6C show examples of heating element configurations;

FIGS. 7A-7B show a top and cross-sectional front view respectively of aremovable cassette lid having an attached heating element;

FIG. 8 shows a flow chart for an exemplary embodiment of a method ofsterilization or sanitization; and

FIG. 9 shows a block diagram of components for monitoring andcontrolling a sanitizer/sterilizer system.

It should be understood that the drawings are not necessarily to scaleunless specifically so indicated. In certain instances, details that arenot necessary for an understanding of the invention or that render otherdetails difficult to perceive may have been omitted. It should beunderstood, of course, that the invention is not necessarily limited tothe particular embodiments illustrated herein.

DETAILED DESCRIPTION OF THE INVENTION

Generally, a sanitizer system and method of use that sanitizes, cools,and stores medical equipment using conduction and a removable cassetteis disclosed. The system and method for sanitizing and storinginstruments minimizes the potential for contamination during andpost-sanitization while also providing a reduced cool-to-coolsanitization total cycle time. In one embodiment, the disclosed systemreduces total cycle time from, for example, from between 50-60 minutesto between 15-20 minutes, preferably from between 35-40 minutes tobetween 12-15 minutes, and more preferably from between 30-35 minutes tobetween 9-10 minutes, allowing an office to manage its patient flow withfewer instruments resulting in a reduction in instrument cost.

The disclosed system may comprise a cassette having a removable lid anda cassette body joined to form an enclosed airtight chamber configuredto hold objects or instruments for sanitization. The pressure within thecassette may be varied from the ambient environment by pulling air outof the chamber through a valve, or by disposing air, an inert gas, orsome other fluid into the chamber to form a pressurized environment,essentially creating a mini vacuum or pressurized chamber. Once theobjects or instruments have been placed in the cassette and a vacuum orpressurized chamber has been created, the cassette may be heated in thesanitizer system to an appropriate temperature for a time sufficient tosanitize the objects or instruments to a level suitable for the desireduse. After sanitization of the objects or instruments, the cassette maybe actively cooled, preferably to a temperature cool enough for a userto handle comfortably, and more preferably to room temperature, foreither immediate use or for storage. To open and remove the objects orinstruments post sanitization, a valve on the cassette may be turnedfrom closed to open. After opening the valve, air may rush into thechamber through the valve producing an audible sound signifying that thechamber has been kept isolated from the ambient environment and istherefore uncontaminated post sterilization. Once the pressure insidethe cassette has reached equilibrium with the ambient environment, thelid may be removed from the cassette body and the instruments, stilldisposed in the cassette, may be accessed for use. The disclosed deviceand method may be used in a variety of fields to include sanitization ofmedical, dental, pharmaceutical, cosmetic, surgical, and orthodonticobjects or instruments.

FIG. 1A shows an exemplary embodiment of a sanitizer system 100. Thesanitizer system comprises a cassette 101, a pressure control element110, a heating element 102, and a cooling element 103. Cassette 101 maybe removably disposed on the heating element or the cooling element ofthe sanitizer system. In FIG. 1A, cassette 101 is in surface contactwith cooling element 103 and heating element 102 is in a loweredposition relative to cooling element 103.

As shown in FIGS. 1A and 1B, the sanitizer system may further comprisean actuator element 111, wherein actuator element 111 is configured tomove one of heating element 102 or cooling element 103 relative to theother of heating element 102 or cooling element 103 through for examplea mechanical connection 112. In a preferable embodiment, the arrows 113in FIG. 1A indicate the direction of movement of heating element 102from an initial lowered position to a raised position relative tocooling element 103. Actuator element 111 may comprise, for example, amotor, cable/pulley, rack/pinion, hydraulic/pneumatic or any otherdevice known in the art having the ability to move the heating orcooling element to a desired position.

FIG. 1B shows the exemplary embodiment of FIG. 1A wherein heatingelement 102 is in a raised position relative to cooling element 103 andcassette 101 is in surface contact with heating element 102. Note that,as depicted in FIGS. 1A and 1B, cassette 101 may only be in surfacecontact with one of the heating element 102 or cooling element 103 whenit is in a raised or a lowered position with respect to the other ofheating element 102 or cooling element 103. To facilitate this motion,one of the heating or cooling element may comprise an opening thereinand the other of the heating or cooling element may be moved through theopening into a raised or lowered position relative to the heating orcooling element with the opening. FIG. 1C shows a photograph of theexemplary embodiment of a sanitizer system 100, as shown in FIGS. 1A-1B.

In an exemplary embodiment, the sanitizer system may use thermoelectriccooling that may actively cool a hot container or cassette therebyreducing the cool-to-cool total cycle time. The cooling element of thesanitizer system may comprise a cooling block 103, which may becomprised of any material with a high enough thermal conductivity foreffective heat transfer. In a preferable embodiment, the cooling blockmay be comprised of brass. The cooling block 103 may be actively cooledvia thermoelectric coolers 130, which in turn, may have their heatdissipated into heat sinks 131. The cooling block 103 may be one solidpiece that extends through an opening into the enclosed environment 119.

The cooling element may be configured to be in surface contact with thecassette such that the cooling element reduces the temperature of thecassette. In addition, the cooling element may comprise a plurality ofelongated cooling members separated by alternating gaps forming acooling platform having a substantially planar cooling surface.

The pressure control element 110 may be configured to fluidly engage,through for example, pressure control engagement element 130 and valve120, with cassette 101 in order to produce a pressure-controlledenvironment within an airtight chamber enclosed by the cassette. Thepressure control element may comprise a vacuum or insertion element 110configured to fluidly engage with cassette 101 and evacuate or insertfluid from the airtight chamber enclosed by the cassette to produce avacuum or pressurized environment therein. The fluid may comprise aliquid or a gas, including but not limited to air, an inert gas, such asargon or neon, or a non-oxidizing gas, such as nitrogen. Vacuum orinsertion element 110 may also comprise a valve (not shown) to controlor monitor the chamber environment, wherein the valve is configured toprovide an audible or visual indication that an airtight seal has beenbroken by actuating the valve from a closed position to an openposition. Sanitizer system 100 may further comprise an indicator 150,such as, for example, a pressure gauge, having indicia that indicate adegree of vacuum or pressure established in the airtight chamber.

FIG. 2A shows a perspective view of a cassette 201 for use in anexemplary embodiment. Cassette 201 comprises a body 202 and a removablelid 203. FIG. 2B depicts a cross-sectional perspective view that showsthe inside of the exemplary embodiment of FIG. 2A. In particular, asshown in FIG. 2B, cassette body 202 and removable lid 203 form anairtight chamber 204 when joined together, wherein the airtight chamber204 is configured to contain an object or instrument for sanitization.Removable lid 203 may comprise a mating groove 212 configured to matewith a mating surface 214 on cassette body 202 to form an airtight seal205. Mating groove 212 may be an O-ring groove containing an O-ring andmating surface 214 may be fabricated from stainless steel, which theO-ring seals against to form airtight seal 205. In addition, removablelid 203 may be held against cassette body 202 with cassette bodyengagement members 216, which may be attached to cassette body 202 andwhich are configured to engage with removable lid engagement members 215in removable lid 203 (best seen in FIG. 2A). Cassette body engagementmembers 216 may be stainless steel toggle clamps that may be welded orotherwise attached to cassette body 202, which may also be fabricatedfrom stainless steel, and cassette lid engagement members may beengagement grooves 215, wherein clamps 216 are configured to latch intoengagement grooves 215. Notably, cassette body engagement members 216and cassette lid engagement members 215 are not limited to clamps andgrooves respectively. In particular, one of cassette body engagementmember 216 or cassette lid engagement member 215 may comprise aprotrusion or tab and the other of cassette body engagement member 216or cassette lid engagement member 215 may comprise an opening,indentation, or recess configured to mate or join with the correspondingprotrusion or tab.

FIGS. 3A and 3B show a top and cross-sectional side view respectively ofa removable lid 303 for use in an exemplary embodiment. Removable lid303 comprises a mating groove 312, which may be an O-ring groove andwhich may contain an O-ring (not shown). The lid 303 may easily beremoved and replaced.

FIGS. 4A and 4B show a top and cross-sectional side view respectively ofa cassette body 402 for use in an exemplary embodiment. Cassette body402 comprises a mating surface 414 configured to mate with an O-ring inthe O-ring groove, as depicted for example in FIGS. 3A and 3B, to forman airtight seal. Cassette body further comprises a valve 420 having theability to be opened and closed. Cassette body 402 and mating surface414 may both be fabricated using stainless steel. Valve 420 may also bestainless steel and may be welded to cassette body 402. Cassette body402 may have no holes or perforations and may be one completely enclosedpiece of stainless steel formed, for example, by folding and weldingstainless steel sheet metal together in a desired geometry. Cassettebody 402 may further comprise cassette engagement members 416, which maybe stainless steel toggle clamps that may be welded to cassette body402. Cassette body engagement members 416 are not limited to clamps butmay also comprise protrusions or tabs, or alternatively, may comprisegrooves, openings, indentations, or recesses configured to mate or joinwith a corresponding protrusion or a tab.

FIG. 5 shows a cross-sectional view of a cassette 501 comprising both acassette body 502 and a removable lid 503 for use in an exemplaryembodiment. Objects or instruments to be sanitized may be disposed incassette 501. Cassette body 502 and removable lid 503 form an airtightchamber 504 when joined together, wherein the airtight chamber 504 isconfigured to contain an object or instrument for sanitization.Removable lid 503 may comprise a mating groove 512 configured to matewith a mating surface 514 on cassette body 502 to form an airtight seal505. The mating groove may be an O-ring groove 512 containing an O-ring513 and mating surface 514 may be fabricated from stainless steel, whichO-ring 513 seals against to form airtight seal 505. In addition,removable lid 503 may be held against cassette body 502 with cassettebody engagement members 516, which may be attached to cassette body 502and which are configured to engage with removable lid engagement members515. Cassette body engagement members may be stainless steel toggleclamps 516 that may be welded or otherwise attached to cassette body502, which may also be fabricated from stainless steel, and removablelid engagement members may be engagement grooves 515, wherein clamps 516are configured to latch into engagement grooves 515. Notably, cassettebody engagement members 516 and cassette lid engagement members 515 arenot limited to clamps and grooves respectively. In particular, one ofcassette body engagement member 516 or cassette lid engagement member515 may comprise a protrusion or tab and the other of cassette bodyengagement member 516 or cassette lid engagement member 515 may comprisean opening, indentation, or recess configured to mate or join with thecorresponding protrusion or tab.

Valve 520 may be a ball valve that may be opened and connected to apressure control element to create a vacuum or pressurized environmentwithin the closed cassette shown in FIG. 5. Valve 520 may be closedwhile the chamber is under vacuum or under pressure, to create a chamberenvironment that is isolated from the ambient environment, essentiallyforming a mini vacuum or pressurized chamber that houses the objects orinstruments. Cassette 501 may further comprise an alignment element on atop surface of the cassette (not shown) and a mating element on a bottomsurface of the cassette (not shown) configured to align and mate with anadjacent cassette having an alignment element and a mating element. Inparticular, these alignment and mating elements would enable a cassetteto be stacked on top of an adjacent cassette for storage or for otherpurposes where stacking cassettes would be advantageous or desirable.

The cassettes and their respective chambers may vary in shape, size, andmaterial. A cassette may be made in any shape or geometry (e.g.cylindrical, spherical, box-shaped, or some other contoured or irregularshape having an internal volume) depending on the instruments anddevices to be sanitized. A cassette may also be any size (e.g. large,medium, or small) suitable for containing the objects for sanitizationor as required by the end user. For example, small cassettes may be usedto hold one standard set or even one tool if desired and the cassettesmay have locations where individual instruments may latch into or besecured onto the base of the cassette. Cassettes may also be largeenough to house several commercially available containers. Additionally,a cassette may be made of any material suitable to be heated and cooled.For example, the removable lid and potentially even the sides of thecassette body may be constructed of a polymer or polymeric material,provided that the polymer can withstand higher temperatures as neededfor sanitization, with only the base, which is in surface contact withthe instruments, constructed of metal to allow heat to be conductedthrough the base to the instruments. The time required to cool the baseof the cassette and instruments to a temperature appropriate for use ofthe instruments may be decreased if plastic or some other appropriatenon-metallic material is used to construct portions of the cassetteprovided that there is less mass to cool as compared with a completelymetallic cassette.

A preferable embodiment of a sanitizer system may further comprise afilter (not shown), which may sanitize the fluid within the airtightchamber 504. Cassette 501 may comprise both an input valve 520 and anoutput valve 521, wherein the input and the output valve may each havean open and a closed position, and wherein when both the input and theoutput valve are in the open position, filtered fluid may be configuredto be delivered through the input valve filling the cassette withfiltered fluid and forcing unfiltered fluid out of the output valve. Thefluid may comprise a liquid or a gas, including but not limited to air,an inert gas, such as argon or neon, or a non-oxidizing gas, such asnitrogen.

The heating element for a sanitizer system may be in surface contactwith the cassette and may also further comprise a plurality of elongatedheating members separated by alternating gaps forming a heating platformhaving a substantially planar heating surface, wherein the heatingplatform conducts heat in a substantially even manner over a surface ofthe cassette. The heat provided by the heating element may raise thetemperature within the airtight chamber of the sanitizer system to atemperature and for a period of time sufficient to sterilize the objectfor sanitization to a level suitable for dental use or surgical use.

FIG. 6A shows an example of a configuration for a heating element 600for a sanitizer system. The heating element may comprise an elongatedmember 601 in a serpentine or sinusoidal configuration as shown forexample in FIG. 6A. Alternatively, elongated members 611 or 612 may beformed in a concentric circular or coiled configuration as shown forexample in the heating elements 610 and 620 FIGS. 6B and 6Crespectively. Note that, as described above, the cooling element mayalso comprise a plurality of elongated cooling members separated byalternating gaps forming a cooling platform having a substantiallyplanar cooling surface. The elongated cooling members may furthercomprise an elongated member in a serpentine or sinusoidal configurationas shown for example in FIG. 6A, or in a concentric circular or coiledconfiguration as shown for example in FIGS. 6B-6C. Additionally, theelongated members of a heating element, formed for example by aserpentine or sinusoidal configuration as shown in FIG. 6A, may beconfigured to interdigitate with or be nested within the elongatedmembers of an adjacent cooling element that may also be formed by aserpentine or sinusoidal configuration. This interdigitated or nestedconfiguration may allow the elongated members of one of the heatingelement or the cooling element to pass between the elongated members ofthe other of the heating element or the cooling element when one of theheating element or the cooling element is raised or lowered with respectto the other of the heating element or the cooling element.

A heating element or cooling element in an embodiment of a sanitizersystem as disclosed herein is not limited to the examples shown and maytake various forms, shapes, configurations and sizes as known in theart.

FIGS. 7A and 7B show a top and cross-sectional front view respectivelyof a removable lid 703 for use in an exemplary embodiment, wherein aheating element 702 is disposed inside the cassette to heat the airtightchamber from within. Removable lid 703 may further comprise electricalcontacts 725 exiting the lid 703 of the cassette through sealed openings735. Removable lid 703 may comprise a mating groove 712, which may be anO-ring groove and which may contain an O-ring (not shown) configured tomate with a mating surface of the cassette body.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be constructed of materials known to provide, orpredictably manufactured to provide, the various aspects of the presentdisclosure. For example, an embodiment of a sanitizer system may bemanufactured using methods and techniques comprising injection molding,computer-numeric control (CNC) machining, and 3-D printing.

FIG. 8 shows an embodiment of a method of sanitizing an object. Themethod 800 comprises: providing an object for sanitization 810; placingthe object for sanitization within a cassette comprising a body and aremovable lid at 820; joining the body and removable lid of the cassetteto form an airtight chamber containing the object for sanitization at830; controlling a pressure in the airtight chamber at 840; heating theairtight chamber using a heating element to raise the temperature withinthe airtight chamber and thereby sanitizing the object for sanitizationcontained within the airtight chamber at 850; maintaining thetemperature for a designated period of time sufficient to sanitize theobject for sanitization at 860; and cooling the object for sanitizationat 870.

In a preferable embodiment of a method of sanitizing an object,providing an object for sanitization at 810 may comprising takinginstruments that have been scrubbed, washed, and chemically treated inaccordance with any requirements, laws, and regulations applicable tothe respective standard for sanitization employed in the industry andplacing them in a cassette (as shown for example in FIG. 2A and FIG. 5).

Joining the body and removable lid of the cassette to form an airtightchamber may comprise placing the lid (as shown for example in FIGS.3A-3B) on the cassette body (as shown for example in FIGS. 4A-4B) sothat an O-ring on the lid forms an airtight seal with a mating surfaceon the cassette body, enclosing the instruments in an airtight chamberas shown in FIG. 5. As depicted and described above in FIGS. 2A-2B andFIG. 5, cassette body engagement members 216 and 516 may be toggleclamps that may comprise rings that can be looped over removable lidengagement members 215 and 516, which may be engagement grooves 515 inthe removable lid. The toggle clamps may then be locked down to form anairtight seal between the O-ring groove 512 of removable lid 512 and themating surface 514 of the cassette body, as shown in FIG. 5. Notably,the method is not limited to the clamps and grooves as described above,but any method to form and maintain an airtight seal between theremovable lid and the cassette body as known in the art may be employed,including for example, using the internal vacuum generated in thechamber or the weight of the lid. The O-ring or other sealing materialused to form an airtight seal between the removable lid and the cassettebody need only satisfy any requirements, laws, and regulationsapplicable to the respective standard for sanitization employed in theindustry.

Controlling a pressure in the airtight chamber at 840 may compriseevacuating fluid from or disposing fluid into the airtight chamber toeither decrease or increase the pressure in order to produce a vacuum orpressurized environment within the airtight chamber. In a preferableembodiment, controlling the pressure may comprise turning a valve 120 asshown in FIGS. 1A-1B into an open position to allow air to flow in andout of the chamber through the valve. At this point, air will only beable to flow in and out of the cassette through the valve because theO-ring has formed an airtight seal between the removable lid and thecassette body. Controlling the pressure may further comprise connectinga nipple of valve 120, with the valve still in an open position, to aninsertion element 110, which may be a vacuum pump, so as to evacuate airfrom the chamber. After the cassette has been evacuated as much aspossible and with the vacuum pump 110 still on and connected to thenipple of valve 120, the valve may be turned to a closed position. Thevacuum pump may be turned off and disconnected from the nipple of thevalve leaving the instruments resting at the bottom of an evacuatedcassette chamber with a pressure different from atmosphere.

The method may further comprise controlling or monitoring the vacuum orpressurized environment within the airtight chamber after the object forsanitization has been sanitized by using an audible or visual indicatorthat the cassette is still under vacuum or is still pressurized.Additionally, as shown in FIG. 5, the cassette may comprise an inputvalve 520 and an output valve 521, and method may further comprise:opening the input valve, opening the output valve, passing a filteredfluid through the input valve into the chamber, forcing unfiltered fluidfrom the chamber through the output valve, pressurizing the chamber, andclosing both valves. The fluid may comprise a liquid or a gas, includingbut not limited to air, an inert gas, such as argon or neon, or anon-oxidizing gas, such as nitrogen.

Heating the airtight chamber at 850 may comprise heating the airtightchamber through thermal conduction, through thermal convection, bycontacting a surface of the cassette with the heating element, or byheating with the heater element disposed inside the cassette. In apreferable embodiment, the cassette may first be placed on the coolingelement 103 of the sanitizer system 100 shown in FIG. 1A. At this time,cooling element 103 is at room temperature because the system has notbeen turned on. The sanitizer system 100 may be turned on in order toactivate the actuator 111 to raise the heating element 102 up through anopening in the cooling element 103 where cassette 101 was initiallyplaced. Heating element 102 makes surface contact with and supportscassette 101, raising the cassette above cooling element 103 so that thecassette is now only resting on heating element 102, as shown in FIG.1B. At this point, only heating element 102 is in surface contact withcassette 101.

Heating element 102 may be turned on and set to a designated or desiredtemperature for an appropriate time to sanitize or sterilize theinstruments disposed in cassette 101 to a level suitable for dental useor surgical use. Heating may be accomplished in any fashion as long asit is compliant with the allotted amount of time at the appropriatetemperature to ensure sanitization or sterilization. Temperature rangesappropriate for sanitizing instruments include 340° F. for a minimum of60 minutes, preferably 360° F. for a minimum of 30 minutes, and morepreferably 375° F. for a minimum of 6 minutes to ensure that theinstruments are sterilized. Commercially available indicators may beused to ensure that the temperature of the cassette chamber has reachedan appropriate sanitization or sterilization temperature for asufficient time to sanitize or sterilize the instruments for surgical,dental, or any other desired use. These indicators may be placed on thebottom of the cassette with the instruments. If there is concern aboutthe entire chamber environment being heated, an indicator could beplaced on top of a material with a low thermal conductivity that canwithstand the higher temperature such as a plastic. The indicator willtherefore not be heated via conduction through the base of the cassettebut through both convection and radiation within the box ensuring thatthe entire environment within the cassette has reached a particulartemperature indicative of being sanitized or sterilized. The method mayalso use a controller or any means known to those skilled in the art tomonitor and/or control the sanitization process or elements (e.g. theheating element or the cooling element) such as by use of programmablelogic controllers.

FIG. 9 shows an embodiment of a sanitizer system that uses a controllerto monitor and/or control the sanitization process and elements thereof.Microcontroller 901 may be connected to and may be used to controlthermoelectric cooler 902, heating element 903, and actuator motor 904through relay boards 905. In addition, microcontroller 901 may receiveinputs from: start/stop push button 920, which may be used to activatethe sanitizer system; contact switch 930, which may be used to indicatea safety interlock on the actuator in lifting the cassette to theheating element; and thermocouple/temperature sensor 912 and infraredcontactless temperature sensor 913, which may be used to monitor thetemperature of the cassette chamber.

In a preferable embodiment, cassette 101 may be heated throughconduction by surface contact with heating element 102. The requiredtemperature may be maintained for a designated period of time sufficientto sanitize or sterilize the instruments at 860, after which heatingelement 102 may be turned off and the actuator 111 may be activated tolower cassette 101 down to rest back in its original position on coolingelement 103 as shown in FIG. 1A.

The instruments for sanitization may be disposed inside the cassette101, and in particular, may rest on the bottom of cassette 101 and maybe heated through conduction via contact with the bottom of cassette101. Additionally, the cassette may comprise support elements (notshown), including for example, holders or racks for supporting orholding the instruments. The support elements may be used for example toprevent unwanted movement of the instruments, to isolate the instrumentsfrom touching one another, or to keep the instruments in a desired orderor configuration during the sanitization process or during storage.

Alternatively, the cassette may be heated in a conventional dry heatconvection oven, wherein the cassette is heated by convection and thetargeted objects for sanitization (e.g. medical instruments) containedwithin the cassette are heated by conduction.

It is also worth noting that cooling the object for sanitization at 870may be accomplished in a multitude of fashions and need not be separatefrom the heating element. For example, a cooling jacket may be providedthat rests on or is otherwise in communication with the heating elementsuch that when the heating element is turned off, a pneumatic valveopens, allowing coolant fluid to flow into the cooling jacket to coolthe cooling element and the cassette. Alternatively, an office watersupply, a closed loop water circulation system connected to arefrigerator, or some other coolant fluid source as known in the art maybe used to flow coolant fluid through the cooling jacket.

In a preferable embodiment, the cassette may be metallic and thus, alongwith being heated via conduction, it may also be actively cooled throughconduction reducing the overall cool-to-cool total cycle time. In thiscase, cooling the object for sanitization at 870 may comprise activatingthermoelectric coolers 130 to actively cool the cooling element 103which is now in surface contact with cassette 101 as shown in FIG. 1A.Heat is removed from the instruments and cassette 101 through conductionvia cooling element 103, which is in turn cooled by thermoelectriccoolers 130.

The thermoelectric coolers 130 may remain on for a time sufficient toallow enough heat to be removed from the cassette as well as theinstruments the cassette is housing so that they are at roomtemperature. Radiative heat sinks 131 may be used to dissipate heat fromthermoelectric coolers 130. Both the thermoelectric coolers and heatsinks may be located outside the enclosed environment 119 where thecassette is being heated to ensure that the thermoelectric coolers donot exceed their maximum operation temperature. The heating element,which is mechanically connected to an actuator, remains off at thisstage and is disposed below the cooling element.

Additionally, programmable logic may be used to simplify the end user'sexperience for the heating and cooling of the cassette chamber in thesanitizer system. For example, the logic may provide error codes in thecase of failure to simplify trouble shooting.

Once cassette 101 and the instruments disposed therein return to roomtemperature, the cassette may be removed from the sanitizer system. Theinstruments disposed in the cassette have thus been sanitized andreturned to room temperature while still under vacuum or pressure, andare ready for use or storage. The cassette may be stored on top of anadjacent cassette.

The system may utilize any means known to those skilled in the art tohandle the loading and/or unloading of the cassette from or onto theheating element or the cooling element. The sanitizer system may also beused to cool more than one cassette at a time and may be enlarged tosanitize several cassettes.

The temperature of the cassette may be monitored at all times for safetyto ensure that no one picks up a hot cassette. Temperature may bemonitored via thermocouples, infrared lasers, color changing indicatorswhich are blue when cold and red when hot, or any other temperaturesensing indicator known in the art or commercially available.

When ready to remove the instruments from the cassette for use, valve120 may be turned to an open position. Air from the ambient environmentwill rush into cassette 101 through the nipple of valve 120 until thepressure within the chamber of cassette 101 and the pressure external tocassette 101 are substantially the same, so as to reach equilibrium. Arush of the air into cassette 101 through valve 120 may provide anaudible signal that the instruments inside cassette 101 have not beencontaminated by the ambient environment. In a preferable embodiment,along with the audible signal, a visual gauge (digital or analog), ortactile signal (i.e. discernable to the touch) may also be provided toindicate that the seal has held and the airtight chamber has not beencompromised or otherwise contaminated by the ambient environment. Theaudible sound may also be enhanced by manipulating the nipple of thevalve to make a whistle noise or other audible sound.

Once valve 120 is open and the chamber of cassette 101 has reachedequilibrium by equalizing the pressure in the chamber with the ambientenvironment, the clamps or other cassette engagement members may beloosened from the removable lid and the lid may be detached from thecassette body. Once the lid has been detached and removed from thecassette body the instruments may be removed from the cassette 101 andare ready for use.

The sanitizer system may be used to sterilize and/or store dental and/ororthodontic instruments. The sanitizer system may also be configured tocomply with or satisfy US government regulatory requirements and/orstandards including: ANSI/AAMI/ISO 20857: 2010 (sterilization of healthcare products—dry heat: requirements for the development, validation androutine control of an industrial sterilization process for medicaldevices); and ANSI/AAMI ST40:2004/(R) 2010 (Table-top dry heat (heatedair) sterilization and sterility assurance in health care facilities,2^(nd) ed).

The cassette used in the sanitizer system isolates the instruments fromthe ambient environment before, during, and after sanitation. Becausethe cassette may also be used as a storage unit, there is no need totransfer the sanitized instruments to plastic bags or to any othersterile container known in the art. In addition, the sanitizer systemreduces the cool-to-cool total cycle time resulting in fastersanitization turnaround times and a reduction in the number ofinstruments needed by an office to maintain a desired patient flow.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure as provided in FIGS. 1-9 are not limited for use indental and/or orthodontic applications, but may be applied for otherpurposes and to many other industries. For example, the sanitizer systemmay be used in hospital settings, surgical settings, veterinaryapplications, food preparation, electronics, pharmaceutical, aerospaceand any application requiring the sanitization or sterilization and/orstorage of sanitized or sterilized instruments, components, or systems.

As will be appreciated, any feature may be used alone or in combinationwith another feature disclosed herein.

While various embodiment of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

While preferred embodiments have been shown and described herein, itwill be obvious to those skilled in the art that such embodiments areprovided by way of example only. Numerous variations, changes, andsubstitutions will now occur to those skilled in the art withoutdeparting from the invention. It should be understood that variousalternatives to the embodiments of the invention described herein may beemployed in practicing the invention. It is intended that the followingclaims define the scope of the invention and that methods and structureswithin the scope of these claims and their equivalents be coveredthereby.

What is claimed is:
 1. A method of sanitizing an object comprising:providing an object for sanitization; placing the object forsanitization within a cassette comprising a body and a removable lidsuch that the object for sanitization is in surface contact with thecassette; joining the body and removable lid of the cassette to form anairtight chamber containing the object for sanitization; controlling apressure in the airtight chamber by forcing fluid into the airtightchamber to increase the pressure and to produce a pressurizedenvironment therein; heating the airtight chamber using a heatingelement to raise the temperature within the airtight chamber and therebysanitizing the object for sanitization contained within the airtightchamber; maintaining the temperature for a designated period of timesufficient to sanitize the object for sanitization; and cooling theobject for sanitization, wherein cooling the object for sanitizationfurther comprises contacting a surface of the cassette with a coolingelement; and moving one of the heating element or the cooling elementrelative to the other of the heating element or cooling element suchthat the cassette is only in surface contact with either the heatingelement or the cooling element.
 2. The method of claim 1, wherein saidheating the airtight chamber comprises heating the airtight chamberthrough thermal conduction.
 3. The method of claim 1, wherein saidheating the airtight chamber comprises heating the airtight chamberthrough thermal convection.
 4. The method of claim 1, wherein saidheating the airtight chamber comprises heating with the heating elementdisposed inside the cassette.
 5. The method of claim 1, wherein saidcontrolling the pressure in the airtight chamber comprises evacuatingfluid from the airtight chamber to decrease the pressure and to producea vacuum environment therein.
 6. The method of claim 5, furthercomprising controlling or monitoring the vacuum environment within theairtight chamber after the object for sanitization has been sanitized byusing an audible or visual indicator that the cassette is still undervacuum.
 7. A method of sanitizing an object comprising: providing anobject for sanitization; placing the object for sanitization within acassette comprising a body and a removable lid; joining the body andremovable lid of the cassette to form an airtight chamber containing theobject for sanitization; forcing fluid into the airtight chamber toincrease the pressure therein; heating the airtight chamber using aheating element to raise the temperature within the airtight chamber andthereby sanitizing the object for sanitization contained within theairtight chamber; maintaining the temperature for a designated period oftime sufficient to sanitize the object for sanitization; cooling theobject for sanitization, wherein cooling the object for sanitizationfurther comprises contacting a surface of the cassette with a coolingelement; wherein the cassette comprises an input valve and an outputvalve, and wherein the method further comprises: opening the inputvalve, opening the output valve, passing sanitized fluid through theinput valve into the airtight chamber, forcing fluid from the airtightchamber through the output valve, pressurizing the airtight chamber, andclosing both valves; and moving one of the heating element or thecooling element relative to the other of the heating element or coolingelement such that the cassette is only in surface contact with eitherthe heating element or the cooling element.
 8. The method of claim 7,wherein said heating the airtight chamber comprises heating the airtightchamber through thermal conduction.
 9. The method of claim 7, whereinsaid heating the airtight chamber comprises heating the airtight chamberthrough thermal convection.
 10. The method of claim 7, wherein saidheating the airtight chamber comprises heating with the heating elementdisposed inside the cassette.
 11. The method of claim 7, furthercomprising stacking the cassette on top of an adjacent cassette.
 12. Themethod of claim 7, further comprising sterilizing the object forsanitization to a level suitable for dental use or surgical use.
 13. Themethod of claim 7, wherein said cooling the object for sanitizationcomprises actively cooling the object for sanitization.
 14. A method ofsanitizing an object comprising: providing an object for sanitization;placing the object for sanitization within a cassette comprising a bodyand a removable lid such that the object for sanitization is in surfacecontact with the cassette; joining the body and removable lid of thecassette to form an airtight chamber containing the object forsanitization; evacuating fluid from the airtight chamber to decrease thepressure and to produce a vacuum environment therein; monitoring thevacuum environment within the airtight chamber by using an audible orvisual indicator; heating the airtight chamber using a heating elementto raise the temperature within the airtight chamber and therebysanitizing the object for sanitization contained within the airtightchamber; maintaining the temperature for a designated period of timesufficient to sanitize the object for sanitization; and cooling theobject for sanitization, wherein cooling the object for sanitizationfurther comprises contacting a surface of the cassette with a coolingelement; and moving one of the heating element or the cooling elementrelative to the other of the heating element or cooling element suchthat the cassette is only in surface contact with either the heatingelement or the cooling element.
 15. The method of claim 14, furthercomprising forcing fluid into the airtight chamber to increase thepressure therein.
 16. The method of claim 14, wherein said heating theairtight chamber comprises heating with the heating element disposedinside the cassette.
 17. The method of claim 14, further comprisingstacking the cassette on top of an adjacent cassette.
 18. The method ofclaim 14, further comprising sterilizing the object for sanitization toa level suitable for dental use or surgical use.
 19. The method of claim14, wherein said cooling the object for sanitization comprises activelycooling the object for sanitization.
 20. The method of claim 14, whereinsaid heating the airtight chamber comprises heating the airtight chamberthrough thermal convection.